Regulatory Affairs Specialist (CMC Lifecycle)

Regulatory Affairs Specialist (CMC Lifecycle)

Teva

Sofia, Bulgaria

The RA CMC Lifecycle Specialist has the responsibility to compile and maintain the CMC part (modules 2.3 and 3) of the medicinal product dossiers for the worldwide registrations of Teva.

How you’ll spend your day

• Actively participate in meetings related to registration procedures or when CMC expertise is needed.
• Collect and critically evaluate data for inclusion in marketing authorization dossiers.
• Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements and trends.
• Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration and respond to queries.
• Actively participate in the change control system and work in line with established processes.
• Prepare the variation packages and other necessary documents as required by the variation process.
• Perform regulatory evaluation and assessment of technical documentation.
• Contribute to renewal applications or annual reports.
• Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and International markets) and pharmacopoeias.
• Support strategic projects such as technical transfers.
• Ensure that all documents and records pertaining to the RA CMC Lifecycle Department are archived properly. Keep departmental database or other tracking systems up to date.

Your experience and qualifications

• University degree, preferably be in possession of a master level of education in ‘Regulatory Disciplines’ or in other area, but pertinent with the field.
• 2-5 years of experience in CMC Regulatory Affairs or in another scientific role in the pharmaceutical industry.
• Knowledge on registration procedures and pharmaceutical regulation.
• Working independently with a moderate level of guidance and direction.
• Very good command of English, speaking and writing.
• Good IT skills.
• Ability to work in team.
• Communication skills with internal and external customers.
• Organisation skills.
• Accuracy in practice and attention to detail.